A randomised controlled trial of a family-group cognitive-behavioural (FGCB) preventive intervention for the children of parents with depression: short-term effects on symptoms and possible mechanisms

OBJECTIVE Parental depression is one of the biggest risk factors for youth depression. This parallel randomized controlled trial evaluates the effectiveness of the German version of the family-group-cognitive-behavioral (FGCB) preventive intervention for children of depressed parents. METHODS Families with (i) a parent who has experienced depression and (ii) a healthy child aged 8-17~years (mean = 11.63; 53% female) were randomly allocated (blockwise; stratified by child age and parental depression) to the 12-session intervention (EG; n = 50) or no intervention (CG; usual care; n = 50). Self-reported (unblinded) outcomes were assessed immediately after the intervention (6~months). We hypothesized that CG children would show a greater increase in self-reported symptoms of depression (DIKJ) and internalising/externalising disorder (YSR/CBCL) over time compared to the EG. Intervention effects on secondary outcome variables emotion regulation (FEEL-KJ), attributional style (ASF-KJ), knowledge of depression and parenting style (ESI) were also expected. Study protocol (Belinda Platt, Pietsch, Krick, Oort, & Schulte-Körne, 2014) and trial registration (NCT02115880) reported elsewhere. RESULTS We found significant intervention effects on self-reported internalising (Formula: see text = 0.05) and externalising (Formula: see text = 0.08) symptoms but did not detect depressive symptoms or parent-reported psychopathology. Parental depression severity did not modify these effects. Both groups showed equally improved knowledge of depression (Formula: see text = 0.06). There were no intervention effects on emotion regulation, attributional style or parenting style. CONCLUSION The German version of the FGCB intervention is effective in reducing symptoms of general psychopathology. There was no evidence that the mechanisms targeted in the intervention changed within the intervention period

Analytical validation of a next generation sequencing liquid biopsy assay for high sensitivity broad molecular profiling.

Circulating tumor DNA (ctDNA) analysis is being incorporated into cancer care; notably in profiling patients to guide treatment decisions. Responses to targeted therapies have been observed in patients with actionable mutations detected in plasma DNA at variant allele fractions (VAFs) below 0.5%. Highly sensitive methods are therefore required for optimal clinical use. To enable objective assessment of assay performance, detailed analytical validation is required. We developed the InVisionFirst™ assay, an assay based on enhanced tagged amplicon sequencing (eTAm-Seq™) technology to profile 36 genes commonly mutated in non-small cell lung cancer (NSCLC) and other cancer types for actionable genomic alterations in cell-free DNA. The assay has been developed to detect point mutations, indels, amplifications and gene fusions that commonly occur in NSCLC. For analytical validation, two 10mL blood tubes were collected from NSCLC patients and healthy volunteer donors. In addition, contrived samples were used to represent a wide spectrum of genetic aberrations and VAFs. Samples were analyzed by multiple operators, at different times and using different reagent Lots. Results were compared with digital PCR (dPCR). The InVisionFirst assay demonstrated an excellent limit of detection, with 99.48% sensitivity for SNVs present at VAF range 0.25%-0.33%, 92.46% sensitivity for indels at 0.25% VAF and a high rate of detection at lower frequencies while retaining high specificity (99.9997% per base). The assay also detected ALK and ROS1 gene fusions, and DNA amplifications in ERBB2, FGFR1, MET and EGFR with high sensitivity and specificity. Comparison between the InVisionFirst assay and dPCR in a series of cancer patients showed high concordance. This analytical validation demonstrated that the InVisionFirst assay is highly sensitive, specific and robust, and meets analytical requirements for clinical applications